MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. XCEL DILATING TIP TROCAR 12MM; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Model Number D12LT

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2020.Event day and event month was not reported.Attempts are being made to retrieve the device.To date, the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the device's safety lock failed.There were no patient consequences.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Date sent: 4/13/2020.D4: batch # r9573n.Investigation summary: the analysis results found that the d12lt device was returned with no damage in the external components.During the functional testing, the bullet retracted, permitting the exposure of the blade during the advancement through the skin test media and returned to safe position upon penetration.The bullet performed as intended without any anomalies noted.It could not be determined what may have caused the event reported.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Brand Name: XCEL DILATING TIP TROCAR 12MM
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9800224
• MDR Text Key: 201013281
• Report Number: 3005075853-2020-01488
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10705036001577
• UDI-Public: 10705036001577
• Combination Product (y/n): N
• PMA/PMN Number: K032676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2023
• Device Model Number: D12LT
• Device Catalogue Number: D12LT
• Device Lot Number: T40059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 03/23/2020
• Patient Sequence Number: 1